Thermo Fisher Scientific Document Reviewer II in Greenville, North Carolina
Responsible for independently reviewing all technical reports and raw data generated in Pharmaceutical Development Services (PDS)-Analytical Development )AD) and assists in preparing summaries of data for submission. Generating ideas and recommendations for system improvement and assistance for scientific writing.
Reviews independently all technical documents including regular technical documents (e.g. batch testing, stability testing and method validation) and special reports (e.g. pre-formulation report and special investigation reports) and associated raw data generated in the PDS-AD with high quality and deliver within agreed schedule.
Ensures the test methods, protocols and Standard Operating Procedures (SOPs) have been followed by the chemists.
Verifies the integrity and traceability of all data generated and reported.
Follows up with chemists to ensure that all necessary corrections are completed in accordance with Good Manufacturing Practices standard.
Notifies supervisor/manager regarding omissions, incomplete testing results or other irregularities.
Trains other reviewers in good documentation practices and the compliance of current quality standards.
May be required to travel to different sites depending on business requirements (as required).
May be essential to perform alternating or rotating shift work (as required).
Other duties as assigned.
Education and Experience:
B.Sc. in Chemistry or related science in a science related to Pharmaceutical Analysis and at least 2 years of pharmaceutical analytical development experience.
Equivalent combinations of education, training, and relevaqnt work experience may be considered.
Basic understanding the common analytical technologies (e.g. High Performance Liquid Chromatography (HPLC), Gas Chromatography, Dissolution, Infrared (IR) and Ultraviolet (UV).
Excellent working knowledge of Good Manufacturing Practices, International Conference of Harmonization (ICH) and United States Food & Drug Administration (FDA) requirements.
Demonstrated computer proficiency with Microsoft Office programs.
Ability to meet deadlines and prioritize projects.
Strong attention to detail.
Excellent written and oral communication skills.
Proficiency with the English Language.
There is little physical effort and fatigue. Walks, stands, lifts small objects and tools, and/or operates keyboard equipment for short duration (e.g. lifts very light items such as a stapler). Regular need to attend to and decipher sensory input that requires diligence and attention to interpret effectively. This is typically because data is technical, legal or financial in nature. (e.g. troubleshooting systems software and hardware problems, analysis of budget statements). Located in a comfortable indoor area. Any unpleasant conditions would be infreque3nt and of short duration.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
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